NGT BioPharma Consultants provide late development services for small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy, and new modalities) focused on advancing assets through pivotal clinical studies, developing commercial Active Pharmaceutical Ingredients and Drug Products, manufacturing processes and process validation, preparing regulatory dossiers for NDA, BLA, and MAA submissions, and other regulatory submissions worldwide, establishing quality systems for successful preapproval inspections, and preparing for commercial launches.